Macrotextured Breast Implants Research Articles

Impact of the withdrawal of macrotextured implant on reconstruction practices

On 22 November 2018, the French Society for Plastic, Reconstructive and Aesthetic Surgery recommended that Allergan® macrotextured breast implants be recalled, a decision endorsed by the French national health products safety agency (ANSM) on 2nd April 2019. At the Georges-François Leclerc Cancer Center (CGFL) in Dijon, we decided to stop using macrotextured implants as of November 2018 in favor of smooth implants. The purpose of this study is to evaluate the impact of the recall of macrotextured implants on breast reconstruction surgical practices and their complications. This is a single-centre, retrospective study performed at the CGFL in Dijon, France. Reconstruction techniques and complications were compared between two periods, i.e. before the recall of macrotextured breast implants (period 1: 1st September 2017-November 22, 2018) and after the recall (period 2: 23 November 2018-31st March 2020). All patients who underwent breast reconstruction for the first time were included. Data were collected from 168 reconstructions in period 2, and 159 in period 2. The rate of use of breast implants during reconstructions decreased significantly in period 2 (53.6% vs. 23.9%; P<0.001). The rate of autologous reconstructions increased significantly for muscle sparing latissimus dorsi (2.4% vs. 12.6%; P<0.001) and exclusive fat grafting (9.5% vs. 21.5%; P<0.01). Clavien-Dindo Stage IIIb complications decreased in period 2 (10% vs. 18.4%; P=0.04). Since the recall of macrotextured breast implants, the reconstruction rate has decreased in our centre in favor of autologous techniques with lower complication rates.

Textured vs. Smooth Breast Implants Using the Jones Criteria-What Is the Currently Available Evidence for BIA-ALCL?: A Systematic Review.

A literature search in PubMed in April 2023 and the article reference list of the French National Agency of Medicine and Health Products decision from 2019 were screened for applicable studies. Only clinical studies where the Jones surface classification could be applied (required information: breast implant manufacturer) for comparison of smooth and textured breast implants were considered. From a total of 224 studies, no articles were included due to the lack of fit to the strict inclusion criteria. Based on the scanned and included literature, implant surface types in relation to the incidence of BIA-ALCL were not evaluated in clinical studies and data from evidence-based clinical sources plays a minor to no role in this context. An international database that combines breast implant-related data from (national, opt-out) medical device registries is, therefore, the best available option to obtain relevant long-term breast implant surveillance data on BIA-ALCL.

The Influence of BIA-ALCL on the Use of Textured Breast Implant and its Placement: A Survey of Dutch Plastic Surgeons.

Breast implant-associated anaplastic large-cell lymphoma (BIA-ALCL) and its association with macrotextured breast implants may have induced plastic surgeons to change their breast augmentation and breast reconstruction practice. The aim of this study was to survey Dutch plastic surgeons about the effects of BIA-ALCL on their choice of breast implant texture and placement technique. An online questionnaire was distributed to all members of the Dutch Association of Plastic Surgeons. Descriptive data were presented as frequencies and percentages. Technique alterations were analyzed by the marginal homogeneity test for paired nominal data. A total of 63 plastic surgeons completed the questionnaire. The majority of respondents altered their use of textured implants due to BIA-ALCL concerns for both breast augmentation and reconstruction (75.4% and 69.8%, respectively; both being statistically significant, P < .001). Microtextured and smooth/nanotextured breast implants are now most frequently used. BIA-ALCL did not influence the placement technique in breast augmentation and reconstruction (87.7% and 94.3%, respectively). Dual-plane breast implant placement is still the most favored technique for breast augmentation, and submuscular placement is still most favored for breast reconstruction. BIA-ALCL has had a significant impact on the use of macrotextured breast implants by Dutch plastic surgeons in both aesthetic and reconstructive breast surgery. Breast implant placement technique has not been affected.

Conduite à tenir devant un sérome tardif péri-prothétique

The widespread use of silicone implants in reconstructive and aesthetic breast surgery led to an increase in the incidence of breast implant associated anaplastic large cell lymphoma, BIA-ALCL, mainly associated with the use of macro-textured breast implants. BIA-ALCL is a serious complication presenting clinically as a late onset periprosthetic seroma. Thus, its occurrence became an alarming sign feared by most plastic surgeons. Therefore, a good knowledge with respect to early diagnosis, subsequent workup, and treatment is crucial in the management of periprosthetic seroma. The diagnosis of late onset seroma is clinically evident. Although idiopathic seroma is the most common cause, BIA-ALCL should be always eliminated. A complete workup is usually necessary. An ultrasound performed by a radiologist specialized in breast imaging followed by an ultrasound guided puncture is imperative. Consequently, the cytological and the bacteriological analysis will orient us toward the etiology (infectious, neoplastic or mechanical). A standardized management of late periprosthetic seroma does not exist, with various factors are to be taken into consideration. These include the surgeon's experience, the diagnosis, and the medical institution facilities. Although idiopathic seroma is managed by a simple puncture and drainage, other causes may require a surgical procedure with implant removal, capsulotomies, and/or total capsulectomies.

Assessment of Risk Factors for Rupture in Breast Reconstruction Patients with Macrotextured Breast Implants

BackgroundBreast implants (BI) are widely used in plastic surgery, though they are not lifetime devices. Average life before rupture is reported to be around 10–15 years. No consensus exists regarding which factors are involved.ObjectivesFollowing FDA recommendations, this study aims at identifying potential risk factors by evaluating their effect on BI rupture cases.MethodsIn this observational study, 763 BI patients were operated between 2003 and 2019, with a mean implant indwelling of 12.2 years. Patients that returned for follow-up were administered a questionnaire regarding postoperative lifestyle and habits. Implant rupture rate was 15.1%, while BI lifespan was 10.1 years. We obtained complete data from 191 breast implant patients (288 implants). Twenty-three potential risk factors were evaluated and divided in four categories: patient-related, surgery-related, postoperative complications/symptoms, and postoperative care/lifestyle habits. Odds Ratio (OR) for each factor was calculated. Linear regression analysis was calculated for those with a significant OR.ResultsWe report 120 patients (195 implants) with intact and 71 (93 implants) with ruptured devices. BIs were macrotextured in 95.1% of cases (86.8% Allergan BIOCELL). OR was significant for underwire bra use (OR: 2.708), car seat belts (OR: 3.066), mammographic imaging (OR: 2.196), weightlifting (OR: 0.407) and carry-on heavy purses and backpacks (OR: 0.347).ConclusionWearing underwire bras, seat belts and undergoing mammography increases the risk of rupture. Weightlifting and carry heavy bags do not increase that risk. Implant rupture is directly linked with time of indwelling. Postoperative recommendations in BI patients should consider findings from our study, though larger multicenter studies should be encouraged.Level of Evidence IVThis journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266.

The Macrotextured Implant Recall: Breast Implant-Associated-Anaplastic Large Cell Lymphoma Risk Aversion in Cosmetic and Reconstructive Plastic Surgery Practices.

The recall of Allergan Biocell (Irvine, CA) devices due to the association between anaplastic large cell lymphoma (ALCL) and macrotextured breast implants means that plastic surgeons are faced with the challenge of caring for patients with these implants in situ. Cosmetic and reconstructive surgeons have been contacting affected patients to encourage them to follow up and discuss the most appropriate risk-reduction strategies. The aim of this study was to evaluate patient concerns about the risk of breast implant-associated ALCL (BIA-ALCL) and to compare management differences between cosmetic and reconstructive patients. A retrospective review was performed of 432 patients with macrotextured implants who presented to clinic after being contacted (121 reconstructive and 311 cosmetic). These records were analyzed for their presenting concerns, surgery wait times, and management plans. Statistical analysis was performed to compare the cohorts, and odds ratios (ORs) were computed to determine the association between patient concerns and their choice of management. After consultation, 59.5% of the reconstructive cohort and 49.5% of the cosmetic cohort scheduled implant removal or exchange. The reconstructive population had a higher rate of ALCL concern (62.7%); however, both cohorts had a significant OR, demonstrating an expressed fear of ALCL likely contributed to their subsequent clinical management (OR cosmetic, 1.66; OR reconstructive, 2.17). Although the risk of ALCL appears to be more concerning to the reconstructive population, both cohorts were equally motivated to have their implants removed. Informing patients about their ALCL risk is crucial to ensure a patient-supported risk reduction plan.

Patient-Reported Outcomes after Subpectoral Breast Augmentation with Microtextured or Macrotextured Implants Using the BREAST-Q.

Background Breast augmentation with implants is the most commonly performed cosmetic plastic surgery in Brazil and worldwide. The aim of this study was to assess patient satisfaction and quality of life following subpectoral breast augmentation with either microtextured or macrotextured implants, using the BREAST-Q. Methods A prospective study was conducted with 40 women with hypomastia undergoing subpectoral breast augmentation. The patients were randomly allocated to two groups to receive either microtextured or macrotextured breast implants. All participants were assessed preoperatively (baseline) and after 2 and 4 months of surgery for quality of life and patient satisfaction with the surgical results, using the BREAST-Q augmentation module, a patient-reported outcome measure. Results The patients had a mean age of 28.9 ± 6.45 years. The microtextured ( n = 20) and macrotextured ( n = 20) groups were homogeneous for sex, age, education level, marital status, and number of children ( p > 0.05). Both groups showed significant improvement in satisfaction with breasts ( p < 0.001), psychosocial well-being ( p < 0.001), and sexual well-being ( p < 0.001) at the 2- and 4-month follow-up visits compared with baseline. The observed improvements were associated with high effect size values of 5.09, 3.44, and 3.90, respectively. In contrast, significant decreases from baseline in physical well-being scores ( p = 0.001) were found 2 and 4 weeks after surgery in both groups. Conclusion Subpectoral breast augmentation with either microtextured or macrotextured breast implants improved satisfaction with breasts and quality of life in patients with hypomastia.

Effect of Breast Silicone Implant Topography on Bacterial Attachment and Growth: An In Vitro Study.

The mechanisms underlying capsular contracture remain unclear. Emerging evidence supports the inflammation hypothesis, according to which bacteria from an adherent biofilm cause chronic inflammation and collagen deposition on the implant and trigger capsular contracture. Our goal was to evaluate the effect of different types of breast implants on the growth of Staphylococcus aureus, S. epidermidis, and Pseudomonas aeruginosa, which are commonly found in biofilms in infection. Bacteria were grown in tryptic soy broth at 37°C for 2, 6, and 24 h and subsequently incubated for 24 h on 12 shell sections of smooth, nano-, and macrotextured breast implants. After incubation, the solutions were ultrasonicated and bacterial numbers were determined by serial dilution. S. aureus were fixed, washed with phosphate-buffered saline, dehydrated in ethanol, and coated with a platinum film to visualize the presence of biofilms by scanning electron microscopy. The numbers of S. aureus and S. epidermidis attached to the smooth and nanotextured surface implants were significantly lower than those on the macrotextured surface for all incubation times, whereas the number of P. aeruginosa was non-significantly lowest on the nanotextured surface after 24h incubation. Biofilms on smooth and nanotextured implant surfaces showed patchy patterns on scanning electron microscopy in contrast to the continuous pattern detected on macrotextured implants. Nanotextured breast implants may limit bacterial growth and thus prevent capsular contracture.

Defining Double Capsules: A Clinical and Histological Study.

Macrotextured breast implants are associated with double capsules. There is little agreement as to what defines double capsules, how they present, and whether different degrees of double capsule exist. This study aimed to define double capsules and report an association between double-capsule type and degree of tissue adherence. Consecutive aesthetic patients undergoing explantation of Biocell (Allergan, Inc., Irvine, CA) implants between May 2018 and November 2018 were included if they were found to have double capsules intraoperatively. Patient demographics, implant characteristics, explantation reason, implant adherence, and intraoperative findings were recorded. Both adherent and double capsules were histologically examined. Data were analyzed by descriptive statistics. Eleven patients had 22 Biocell implants explanted during the study period. The average explantation time was 8.0 years. Sixteen implants were found to have some degree of nonadherence, and all areas of nonadherence were associated with double-capsule formation. Double capsules were either partial or complete. The architecture of the inner layer of double capsules varied between an organized capsular layer and a thin area of nascent capsule. Histologically, all capsular specimens demonstrated an overall hypocellular fibrous capsule with scattered chronic inflammatory infiltrates. Synovial metaplasia was present in all capsule types and spaces/cracks in the capsule were disproportionately represented in partially adherent capsules. This is the first study to identify a clinical and pathological correlation between double capsules and failed tissue adherence. Double capsules represent a spectrum of inner capsule formation ranging between nascent capsular tissue to a mature inner capsular layer.

Analysis of Allergan's Biocell Implant Recall in a Major University Breast Center.

In May 2019, Health Canada released a national recall of all macrotextured breast implants that later became international in July 2019 regarding increasing accounts of suspected breast implant-associated anaplastic large cell lymphoma. In Canada, this recall targeted Allergan's Biocell implants. This report presents the postmortem of this comprehensive single-center recall, which had to be undertaken in a limited time. Four months after the beginning of the recall, the authors analyzed the transcript of meetings to characterize the team assembled during the recall. Then, to reconstruct the systemic work plan as well as the crucial steps and actors of the recall process, a chronologic table of the 5 meetings held during the recall, agendas and transcripts of every meeting, electronic correspondences, and other documents created during the recall were consulted. Between 1996 and 2018, 1260 women were affected by the recall, meaning that they received Allergan's macrotextured implants. Ninety-two patients underwent explantation of the device or will undergo implant explantation. To this day, no patient was diagnosed with breast implant-associated anaplastic large cell lymphoma. Our center's experience highlights the utmost importance of building a national breast implants registry. We recommend breast centers to develop preestablished crisis centers and train staff to better prepare for future device recalls and minimize waste of time. Finally, we believe that implants should be identified based on the characteristics rather than their brand name.

Editorial on the article “Risk of breast implant associated anaplastic large cell lymphoma in a cohort of 3546 women prospectively followed long term after reconstruction with macro-textured breast implants

Editorial on the article “Risk of breast implant associated anaplastic large cell lymphoma in a cohort of 3546 women prospectively followed long term after reconstruction with macro-textured breast implants

Risk of breast implant associated anaplastic large cell lymphoma (BIA-ALCL) in a cohort of 3546 women prospectively followed long term after reconstruction with textured breast implants

The risk of BIA-ALCL for patients with textured breast implants has been estimated between 1/2832 and 1/30,000 women. Existing studies estimating the numbers exposed and at risk, may have under reported cases, and/or lacked comprehensive follow-up. Our objective is to determine the risk of BIA-ALCL in a defined cohort of patients reconstructed with macro-textured breast implants and consistently followed long-term. A prospective cohort study was conducted in patients who underwent breast reconstruction by a single surgeon at Memorial Sloan Kettering Cancer Center (MSKCC) from December 1992 to December 2017. Major events related to implants were prospectively recorded. We identified cases of BIA-ALCL by cross-checking clinical, pathology and external records data. Patients were followed until lymphoma occurrence or last follow-up. The primary outcomes were incidence rate per person-years and cumulative incidence. From 1992 to 2017, 3546 patients underwent 6023 breast reconstructions, mainly after breast cancer removal, or contralateral prophylactic mastectomy, using macro-textured surface expanders and implants. All reconstructions were performed by a single surgeon (PGC). Median follow-up was 8.1 years (range, 3 months - 30.9 years). Ten women, 1/354, developed ALCL after a median exposure of 11.5 years (range, 7.4-15.8 years). Overall risk of BIA-ALCL in our cohort is 1/355 women or 0.311 cases per 1000 person-years (95% CI 0.118 to 0.503). This study, the first to evaluate the risk of macro-textured breast implants from a prospective database with long term follow-up, demonstrates that the incidence rate of BIA-ALCL may be higher than previously reported. These results can help inform implant choice for women undergoing breast reconstruction.

SMS-Split Muscle Support: A Reproducible Approach for Breast Implant Stabilization.

Recent concerns regarding the association between macrotextured breast implants and anaplastic large cell lymphoma (ALCL) have led to renewed interest in the use of devices with less texturing. Smooth implants appear to have a decreased risk of ALCL; however, low implant adherence has led to questions about implant stabilization and bottoming-out. The senior author has used a split muscle support (SMS) technique to help support the implant infero-laterally in over 380 breast augmentations and augmentation-mastopexy using smooth implants, with a low complication and reoperation rate. A retrospective chart review of 387 consecutive breast augmentation and augmentation-mastopexy patients operated on by the senior author over 24months was performed. The SMS technique was classified in three grades according to amount of implant support by the pectoralis major muscle. Patients were followed for an average of 13months. Major complications occurred in seven (1.9%) patients, of which five (1.4%) were considered implant-related. There were one case of implant rotation and three cases of malposition during the transition from microtexture to nanotexture implants and one case of capsular contracture in a previously irradiated breast. Three post-massive weight loss patients required reoperation for further skin adjustment, and one patient requested upsizing of her implants at 3months. The SMS technique is easily reproducible, adjustable intraoperatively according to patient characteristics, and helps stabilize breast implants. With increasing patient awareness regarding ALCL, the association of smooth implants along with the varying degrees of implant support afforded by SMS can help achieve a low complication and reoperation rate. This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266.

Macrotextured Breast Implants with Defined Steps to Minimize Bacterial Contamination around the Device: Experience in 42,000 Implants

Bacteria/biofilm on breast implant surfaces has been implicated in capsular contracture and breast implant-associated anaplastic large-cell lymphoma (ALCL). Macrotextured breast implants have been shown to harbor more bacteria than smooth or microtextured implants. Recent reports also suggest that macrotextured implants are associated with a significantly higher incidence of breast implant-associated ALCL. Using techniques to reduce the number of bacteria around implants, specifically, the 14-point plan, has successfully minimized the occurrence of capsular contracture. The authors hypothesize that a similar effect may be seen in reducing the risk of breast implant-associated ALCL. Pooled data from eight plastic surgeons assessed the use of macrotextured breast implants (Biocell and polyurethane) and known cases of breast implant-associated ALCL. Surgeon adherence to the 14-point plan was also analyzed. A total of 42,035 Biocell implants were placed in 21,650 patients; mean follow-up was 11.7 years (range, 1 to 14 years). A total of 704 polyurethane implants were used, with a mean follow-up of 8.0 years (range, 1 to 20 years). The overall capsular contracture rate was 2.2 percent. There were no cases of implant-associated ALCL. All surgeons routinely performed all 13 perioperative components of the 14-point plan; two surgeons do not routinely prescribe prophylaxis for subsequent unrelated procedures. Mounting evidence implicates the role of a sustained T-cell response to implant bacteria/biofilm in the development of breast implant-associated ALCL. Using the principles of the 14-point plan to minimize bacterial load at the time of surgery, the development and subsequent sequelae of capsular contracture and breast implant-associated ALCL may be reduced, especially with higher-risk macrotextured implants. Therapeutic, IV.

The double capsules in macro-textured breast implants

Breast implants are amongst the most widely used types of permanent implants in modern medicine and have both aesthetic and reconstructive applications with excellent biocompatibility. The double capsule is a complication associated with textured prostheses that leads to implant displacement; however, its etiology has yet to be elucidated. In this study, 10 double capsules were sampled from breast expander implants for in-depth analysis; histologically, the inner capsular layer demonstrated highly organized collagen in sheets with delamination of fibers. At the prosthesis interface (PI) where the implant shell contacts the inner capsular layer, scanning electron microscopy (SEM) revealed a thin layer which mirrored the three-dimensional characteristics of the implant texture; the external surface of the inner capsular layer facing the intercapsular space (ICS) was flat. SEM examination of the inner capsule layer revealed both a large bacterial presence as well as biofilm deposition at the PI; a significantly lower quantity of bacteria and biofilm were found at the ICS interface. These findings suggest that the double capsule phenomenon's etiopathogenesis is of mechanical origin. Delamination of the periprosthetic capsule leads to the creation of the ICS; the maintained separation of the 2 layers subsequently alters the biostability of the macro-textured breast implant.

Commentary on: Benefits and Limitations of Macrotextured Breast Implants and Consensus Recommendations for Optimizing Their Effectiveness.

Every time I’m in London, I visit my favorite restaurant in Knightsbridge for the chef’s famous pistachio souffle. It never ceases to amaze me how, night after night, year after year, his superb technique produces a perfect and reproducible outcome. Is it the expensive ingredients that the chef selects, or is it his oven that creates this work of art? More likely it is his critical attention to detail, combined with years of experience. The process of breast augmentation has been well described1 and involves a multitude of decisions between the physician and patient. Biodimensional planning allows a shift away from the older “volume” thinking in implant selection toward shaping the breast in a more controlled fashion with implants that provide relative form stability. The authors acknowledge that implant selection, surgical technique, and postoperative management vary depending on the implant selected and share their international experience with the Allergan Natrelle (Allergan, Irvine, California) range of implants with macrotextured shell surfaces.2 They define 3 different-textured surfaces by pore size, classifying Allergan’s Biocell open-pore surface, with the largest diameter, as macrotextured. They describe Mentor’s Siltex (Mentor Worldwide LLC, Santa Barbara, California) surface as microtextured and Sientra’s “True” (Sientra, Santa Barbara, California) texture as intermediate, since the pore size of their textured surface was not defined. In the United States, surgeon experience with textured surface implants differs from …

Benefits and Limitations of Macrotextured Breast Implants and Consensus Recommendations for Optimizing Their Effectiveness.

Implant texture is an important factor influencing implant selection for breast augmentation. Natrelle Biocell implants are characterized by macrotextured shell surfaces containing irregularly arranged concavities with large open-pore diameters and depths. These properties facilitate adhesion of the implant to the surrounding tissue, thereby promoting implant immobilization. Relative to implants with other surfaces, macrotextured implants offer low rates of capsular contracture; low rates of malposition, rotation, and rippling; and high rates of patient satisfaction. However, macrotextured implants are associated with a slightly higher risk of double capsule and late seroma. The surgeon can minimize these risks with straightforward techniques that encourage tissue adhesion. This report presents experience-based recommendations to optimize the effectiveness of Biocell anatomic implants. The authors discuss the application of best practices to all aspects of the breast implantation process, from implant selection and surgical planning to operative technique and postoperative management. LEVEL OF EVIDENCE 3.